{"schemaVersion":"jobsearcher.job.v1","id":"a7a2c6e868db98c8bfbc5c01","url":"https://jobsearcher.com/jobs/a7a2c6e868db98c8bfbc5c01","canonicalUrl":"https://jobsearcher.com/jobs/a7a2c6e868db98c8bfbc5c01","title":"Quality Engineer","description":"For Senior Quality Engineering Specialist services in the Quality Assurance / QA Engineering (FUME: Facilities, Utilities, Maintenance & Engineering) area.\n\nWHAT MAKES YOU A FIT:\n\nThe Technical Part:\n\nBachelor’s degree in Engineering (Chemical, Biotechnical, Biomedical, or Mechanical) and at least five (5) years of experience in automated bulk pharmaceutical GMP operations (Production, Engineering, QA, or Technical Services), with understanding of facilities, utilities, maintenance, commissioning & qualification, and quality systems.\nBilingual: Spanish and English (verbal/ written)\nAvailability to support a 24/7 operation, including irregular hours, shift rotations, weekends, holidays, and emergency situations according to business needs.\nExperience in:\nGMP pharmaceutical or biologics manufacturing environments, including Facilities, Utilities, Maintenance, and Engineering (FUME) systems.\nQuality Systems and computer platforms (e.g., Microsoft Office, TrackWise, Veeva QDocs, QMS, Kneat, GMARS).\nCommissioning, qualification, validation, and engineering documentation processes.\nInvestigations, Root Cause Analysis (RCA), CAPA, change control, and risk management methodologies (FMEA preferred)..\nGood Documentation Practices (GDP), data integrity principles, regulatory compliance, and inspection readiness activities.\n\nThe Personality Part:\n\nOur Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?\n\nAS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)\n\nServe as a technical resource for initiatives and projects related to assets (equipment/facilities), utilities, and processes to support compliant deliverables.\nSupport monitoring of qualified utilities performance against internal and external quality requirements and regulations.\nSupport execution of maintenance, engineering, and qualification activities and strategies.\nSupport event investigations and participate in Root Cause Analysis led by QA Engineers.\nSupport problem solving and risk management activities.\nSupport change controls development and implementation.\nEnsure assigned documentation has good technical writing and complies with Good Documentation Practices (GDP) and data integrity requirements.\nNotify the assigned QA Engineer or Quality management of significant quality-related issues in a timely manner.\n\nWHO WE ARE:\n\nWe are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!\n\nAre you the Next Piece?\nyQV2iPMAAD","company":"Flexible Integrated Technical Services","rawCompany":"flexible integrated technical services","city":"Washington","state":"DC","isRemote":false,"isActive":false,"createdAt":"2026-09-21T09:54:43.905Z","occupations":[{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer","description":"For Senior Quality Engineering Specialist services in the Quality Assurance / QA Engineering (FUME: Facilities, Utilities, Maintenance & Engineering) area.\n\nWHAT MAKES YOU A FIT:\n\nThe Technical Part:\n\nBachelor’s degree in Engineering (Chemical, Biotechnical, Biomedical, or Mechanical) and at least five (5) years of experience in automated bulk pharmaceutical GMP operations (Production, Engineering, QA, or Technical Services), with understanding of facilities, utilities, maintenance, commissioning & qualification, and quality systems.\nBilingual: Spanish and English (verbal/ written)\nAvailability to support a 24/7 operation, including irregular hours, shift rotations, weekends, holidays, and emergency situations according to business needs.\nExperience in:\nGMP pharmaceutical or biologics manufacturing environments, including Facilities, Utilities, Maintenance, and Engineering (FUME) systems.\nQuality Systems and computer platforms (e.g., Microsoft Office, TrackWise, Veeva QDocs, QMS, Kneat, GMARS).\nCommissioning, qualification, validation, and engineering documentation processes.\nInvestigations, Root Cause Analysis (RCA), CAPA, change control, and risk management methodologies (FMEA preferred)..\nGood Documentation Practices (GDP), data integrity principles, regulatory compliance, and inspection readiness activities.\n\nThe Personality Part:\n\nOur Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?\n\nAS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)\n\nServe as a technical resource for initiatives and projects related to assets (equipment/facilities), utilities, and processes to support compliant deliverables.\nSupport monitoring of qualified utilities performance against internal and external quality requirements and regulations.\nSupport execution of maintenance, engineering, and qualification activities and strategies.\nSupport event investigations and participate in Root Cause Analysis led by QA Engineers.\nSupport problem solving and risk management activities.\nSupport change controls development and implementation.\nEnsure assigned documentation has good technical writing and complies with Good Documentation Practices (GDP) and data integrity requirements.\nNotify the assigned QA Engineer or Quality management of significant quality-related issues in a timely manner.\n\nWHO WE ARE:\n\nWe are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!\n\nAre you the Next Piece?\nyQV2iPMAAD","datePosted":"2026-09-21T09:54:43.905Z","dateModified":"2026-09-21T09:54:43.905Z","hiringOrganization":{"@type":"Organization","name":"Flexible Integrated Technical Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Washington","addressRegion":"DC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a7a2c6e868db98c8bfbc5c01"},"url":"https://jobsearcher.com/jobs/a7a2c6e868db98c8bfbc5c01"}}